Replacing the native mitral valve with the ReValve System
A Clinical Study Evaluating the Replacement of the Native Mitral Valve Using the ReValve System
This study will test whether replacing the native mitral valve with the ReValve System helps adults with symptomatic, clinically significant mitral regurgitation who are appropriate candidates for mitral valve surgery.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | ReValve Solutions Inc. Industry-sponsored |
| Locations | 3 sites (Tbilisi and 2 other locations) |
| Trial ID | NCT07450911 on ClinicalTrials.gov |
What this trial studies
This Phase 1 interventional trial tests the ReValve System as a surgical replacement for the native mitral valve in adults with symptomatic, clinically significant mitral regurgitation. Eligible participants must have at least moderate-to-severe MR (≥3+), recent qualifying transthoracic and transesophageal echocardiograms, NYHA class II–III or ambulatory IV status, LVEF ≥30%, and LVESD ≤65 mm. The procedure involves surgical implantation of the ReValve device at participating centers in Tbilisi, Georgia, with scheduled follow-up to monitor device safety and early clinical outcomes. The sponsor is ReValve Solutions Inc.
Who should consider this trial
Good fit: Adults over 18 with symptomatic, clinically significant mitral regurgitation (≥3+), NYHA class II–III or ambulatory IV, LVEF ≥30%, LVESD ≤65 mm, and deemed appropriate for mitral valve surgery are the intended candidates.
Not a fit: Patients with untreated clinically significant coronary artery disease, LVEF below 30%, very large left ventricles (LVESD >65 mm), or those not suitable for surgical valve replacement are unlikely to benefit from this procedure.
Why it matters
Potential benefit: If successful, the ReValve System could reduce mitral regurgitation and related symptoms, potentially improving heart function and quality of life for surgical candidates.
How similar studies have performed: Some transcatheter and surgical mitral valve replacement approaches have shown promise, but fully replacing the native mitral valve with novel devices like ReValve remains early and investigational.
Eligibility criteria
Show full inclusion / exclusion criteria
Key Inclusion Criteria: * Symptomatic MR (≥3+) due to ischemic and non-ischemic cardiomyopathy etiology determined by assessment of a qualifying transthoracic echocardiogram (TTE) obtained within 60 days and transesophageal echocardiogram (TEE) obtained within 90 days prior to subject registration, with MR severity based principally on the TTE study. * New York Heart Association (NYHA) Functional Class II, III or ambulatory IV. * Left Ventricular Ejection Fraction (LVEF) is ≥30% (within 90 days prior to subject registration, assessed by the site using any one of the following methods: echocardiography, contrast left ventriculography, gated blood pool scan or cardiac magnetic resonance imaging (MRI)). * Age greater than 18 years * Left Ventricular End Systolic Dimension (LVESD) is ≤ 65 mm assessed by site based on a transthoracic echocardiographic (TTE) obtained within 90 days prior to subject consent. Key Exclusion Criteria: * Untreated clinically significant coronary artery disease requiring revascularization. * Need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months. * Status 1 heart transplant or prior orthotopic heart transplantation * Cerebrovascular accident within 30 days prior to subject's consent * Pregnant or planning pregnancy within next 12 months. * Currently participating in an investigational drug or another device study. * Evidence of LV or left atrium (LA) thrombus, vegetation or mass * Known hypersensitivity or contraindication to procedural, post procedural medication (e.g., contrast solution, anticoagulation therapy) or hypersensitivity to nickel or titanium.
Where this trial is running
Tbilisi and 2 other locations
- Healthycore — Tbilisi, Georgia (Recruiting)
- Tbilisi Heart and Vascular Center — Tbilisi, Georgia (Recruiting)
- Tiblisi Heart Center — Tbilisi, Georgia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.